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CTRI Number  CTRI/2017/10/010136 [Registered on: 18/10/2017] Trial Registered Retrospectively
Last Modified On: 16/10/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Microsurgical management Of Gingival Recession Defects With Autologous Platelet Rich Fibrin (PRF) And Autogenous Connective Tissue Graft (CTG) In Conjunction With Coronally Advanced Flap: A Comparative Clinical Study 
Scientific Title of Study   Treatment Of Gingival Recession Defects With Autologous Platelet Rich Fibrin (PRF) And Autogenous Connective Tissue Graft (CTG) In Conjunction With Coronally Advanced Flap Using Microsurgical Technique: A Comparative Clinical Study 
Trial Acronym  PRF&CTG 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Archana Kumar 
Designation  Postgraduate Student 
Affiliation  Saraswati Dental College, Lucknow 
Address  Department of Periodontology, Saraswati Dental College, 233, Tiwariganj, Faizabad Road, Chinhat, Lucknow

Lucknow
UTTAR PRADESH
226028
India 
Phone    
Fax    
Email  archanakumar.archana@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vivek Kumar Bains 
Designation  Professor 
Affiliation  Saraswati Dental College, Lucknow 
Address  Department of Periodontology, Saraswati Dental College, 233, Tiwariganj, Faizabad Road, Chinhat, Lucknow

Lucknow
UTTAR PRADESH
226028
India 
Phone  9935023439  
Fax    
Email  doc_vivek76@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Vivek Kumar Bains 
Designation  Professor 
Affiliation  Saraswati Dental College, Lucknow 
Address  Department of Periodontology, Saraswati Dental College, 233, Tiwariganj, Faizabad Road, Chinhat, Lucknow

Lucknow
UTTAR PRADESH
226028
India 
Phone  9935023439  
Fax    
Email  doc_vivek76@yahoo.co.in  
 
Source of Monetary or Material Support  
Self Funded Infrastructural to carry out study was provided by Saraswati Dental Colege, Lucknow 
 
Primary Sponsor  
Name  Saraswati Dental College Lucknow 
Address  Saraswati Dental College, 233, Tiwariganj, Faizabad Road, Chinhat, Lucknow 
Type of Sponsor  Other [Infrastructural support by Institution] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vivek Kmuar Bains  Sraswati Dental College, Lucknow  Department of Peridontology, Saraswati Dental College, 233, Tiwariganj, Faizabad Road, Chinhat, Lucknow
Lucknow
UTTAR PRADESH 
9935023439

doc_vivek76@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Insitutional Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Dental patients having Class I and Class II gingival resession in uppr anterior teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Coronally advanced flap  Treatment of gingival recession using coronally advanced flap procedure 
Comparator Agent  Platelet rich fibrin, Connective tssue graft, CAF alone (Control)  Gingival recession sites were treated with Coronally advanced flap with platlet rich fibrin, connective tissue graft, or alone  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Patients (1) having at least one tooth in maxillary anterior teeth region with Millers Class I or Class II labial gingival recession defect; (2) in good general health (ASA-I) with no contraindications for periodontal surgery; (3) not using antibiotics, corticosteroids, chemotherapeutics, immunomodulators, or others that modify the results of periodontal therapy during the last six months; (4) selected teeth must be free of endodontic treatment, buccal or interproximal restoration; (5) who have not undergone any periodontal treatment in the preceding six months of initial examination. 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Probing pocket depth,
Clinical attachment level,
Horizontal gingival recession,
Vertical gingival recession,
Hypersensitivity score,
Patient esthetic score,
Patient comfort score,
at 3 months and 6 months 
At 3 months and 6 months post-intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Gingival thickness
Patient esthetic score,
hypersenstivity score at 10 days, 3 months and 6 months 
3 months and 6 months 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" 
Phase of Trial   N/A 
Date of First Enrollment (India)   19/12/2013 
Date of Study Completion (India) 25/11/2015 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   The paper is published. DOI: 10.4103/ccd.ccd_70_17 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Purpose: To evaluate autologous Platelet Rich Fibrin (PRF) and autogenous Connective Tissue Graft (CTG) in gingival recession defects in conjunction with coronally advanced flap (CAF) using microsurgical technique.

Materials and Methods: Forty-five class I and II recession defects were randomly equally (n=15) divided into three groups: Group I sites treated with CAF with PRF; Group II sites treated with CAF with CTG and Group III sites treated with CAF alone using microsurgical approach in 36 patients.  Parameters recorded were vertical (VGR) and horizontal gingival recession (HGR), % Complete root coverage (CRC), Patient comfort score (PCS), Patient esthetic score (PES) and Hypersensitivity score (HS) at 10 days, 3 months and 6 months.

Results: CAF surgery alone and in combination with PRF or CTG, are effective  procedures to cover denuded roots with mean VGR values of 1.26±0.70 mm (74.4%),  1.26±0.59 mm (58%) and 1.06±0.79 mm (53.3%) for Group I, II and III. In terms of complete root coverage (CRC) achieved at 6 months, results showed that 100% CRC was obtained in 60 % sites of Group I, 20 % sites of Group II and 27% in Group III. Patient response and acceptance for surgical treatment modality in terms of PCS and PES was highest for Group I (PRF and CAF) followed by Group III, and Group II; and there was decrease in hypersensitivity score (HS) for Group I (PRF and CAF) while no significant changes in HS scores were observed for Group II and Group III. At the end of six months follow-up there was significant increase in gingival thickness measurements using transgingival probing in Group II, whereas non-significant changes were observed in Group 1and Group III.

Conclusions: Long term multicentric randomized controlled clinical study may be necessary to evaluate the clinical outcome for autologous PRF in comparison to CTG and CAF alone.

 
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